Effects of Ivabradine on Residual Myocardial Ischemia After PCI

• Status: Completed
• Trial end date: 2017-03-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Policlinico Umberto I

Criteria

Inclusion Criteria:

• coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);

• percutaneous revascularization with stent implantation at least one;

• signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;

• ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);

• good acoustic window;

• age ≥ 18 years.

Exclusion Criteria:

• drugs intolerance or hypersensitivity

• EF ≤ 40 %

• NYHA class III to IV;

• CCS IV

• atrial fibrillation or flutter

• presence of a pacemaker or implantable defibrillator

• II or III degree AV block

• HR ≤ 70 bpm at rest or sick sinus syndrome

• any condition that could interfere with the ability to exercise stress test like Wolff- Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy;

• rate-corrected QT interval (QTc) greater than 500 ms or the use of drugs that prolong the QTc interval

• symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)

• severe liver disease and severe renal impairment (creatinine clearance ≤ 30 ml/min)

• electrolyte disorders

• uncontrolled thyroid disease

• pregnancy.